[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613029":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":40,"studyPopulation":34,"armGroups":41,"interventions":54,"overallOfficials":34,"centralContacts":63,"locations":69,"responsibleParty":80,"collaborators":34,"id":83,"slug":34,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":34,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":34,"enrollmentInfo":91,"targetDuration":34,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":105,"whyStopped":34,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Kocaeli University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Anxiety Level (STAI-SF)","ssessment of the effect of the music therapy intervention on the anxiety levels of cancer patients receiving curative radiotherapy, using the State-Trait Anxiety Inventory-Short Form (STAI-SF). The measured difference will be compared between the intervention group and the control group.","mmediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).",{"measure":14,"description":15,"timeFrame":16},"Change in Stress Level (SDT)","Assessment of the effect of the music therapy intervention on the general distress\u002Fstress levels experienced by cancer patients receiving curative radiotherapy, using the Symptom Distress Thermometer (SDT). The measured difference will be compared between the intervention group and the control group.","Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).",[18,22],{"measure":19,"description":20,"timeFrame":21},"Change in Procedural Pain Level (VAS)","Assessment of the effect of the music therapy intervention on the severity of pain felt during or related to the radiotherapy procedure, using the Visual Analog Scale (VAS). The measured difference will be compared between the groups.","Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session",{"measure":23,"description":24,"timeFrame":25},"Patient Satisfaction Level (VAS)","Assessment of the effect of the music therapy intervention on patients' overall satisfaction levels with their radiotherapy experience, using the Visual Analog Scale (VAS). Satisfaction scores will be compared between the groups.","Immediately after the end of the radiotherapy session (Post-test).",[27],{"measure":28,"description":29,"timeFrame":30},"Baseline Information Level (EORTC QLQ-INFO25)","Determination of the baseline Information Levels of enrolled patients using the EORTC QLQ-INFO25. This is used to assess baseline similarity between groups, and the potential effect of the information level on other parameters will also be analyzed.","At the start of the study (Pre-test).",{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":34,"timePerspective":34,"maskingInfo":36},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":37,"maskingDescription":34,"whoMasked":38},"SINGLE",[39],"OUTCOMES_ASSESSOR","This study is a single-blind randomized controlled trial 20202020evaluating the effect of music therapy in managing the emotional and physical difficulties experienced by cancer patients who are newly starting curative radiotherapy (RT).Study Site: The study will take place at the Kocaeli University Hospital Radiation Oncology Unit.Objectives: The primary aim is to examine the effect of music therapy on anxiety, stress, pain, and patient satisfaction, and to determine how it can improve the RT experience.Intervention Application:Timing and Duration: Music therapy will be administered during the first RT session in sessions lasting 15-20 minutes. (Literature reports that $\\\u003C20$ minutes reduces anxiety ).Provider: The intervention will be administered by a certified music therapist. Music Selection: Patients will be asked to choose music that has a meditative effect, is instrumental (without lyrics), and lacks peaks (sudden attacks), based on their preference and inclination. The music options provided will include Far Eastern music, music accompanied by a light-beat rhythm instrument (bendir), Ney-heavy Mesnevi music with meditative effects, and meditative Saba makam music.Listening Method: The patient's selected music will be played via headphones for 15 minutes before the session, and as ambient listening during the session. For patients with head and neck or brain cancer, only ambient listening will be used during the procedure for consistency.Data Collection and Timeline:Measurement Location: Measurements will be taken by researchers at the Kocaeli University Radiation Oncology Unit.Study Duration: The study starts on December 1, 2025, and ends on January31, 2026, with a total duration of 7 months.\n\nStatistical Analysis:The collected data will be analyzed using the following methods: Between-group comparisons: Independent Sample T-test or Mann-Whitney U test37.Pre-post changes: Repeated Measures ANOVA.The significance level is set at $p\\\u003C0.05.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Music Therapy Group (Experimental Arm)","EXPERIMENTAL","Description: Consists of patients receiving curative radiotherapy (RT) who receive the music therapy intervention in addition to standard care to improve their radiotherapy experience.",[47],"Other: Music Therapy",{"label":49,"type":50,"description":51,"interventionNames":52},"Control Group (Standard Care Arm)","ACTIVE_COMPARATOR","Description: Consists of patients receiving curative radiotherapy (RT) who receive only the standard radiation oncology care as per hospital protocol during their treatment.",[53],"Other: Standard Care (in control arm)",[55,59],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":34},"Music Therapy","Intervention: A personalized 15-20 minute music listening session is administered by a certified music therapist during the first session of radiotherapy.\n\nPatients select from a list of meditative, instrumental (wordless), and music that lacks peaks (sudden attacks).\n\nMusic is presented via headphones before the session and as ambient listening during the session.",[43],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":34},"Standard Care (in control arm)","Intervention: These patients do not receive the music therapy intervention during their radiotherapy treatment.",[49],[64],{"name":65,"role":66,"phone":67,"phoneExt":34,"email":68},"Ünal Önsüz","CONTACT","+905444416990","unal.onsuz@kocaeli.edu.tr",[70],{"facility":71,"status":34,"city":72,"state":34,"zip":34,"country":73,"countryCode":34,"cosmosGeoPoint":74,"geoPoint":79,"contacts":34},"Kocaeli University Hospital","Kocaeli","Turkey (Türkiye)",{"type":75,"coordinates":76},"Point",[77,78],27.51145,39.62497,{"lat":78,"lon":77},{"type":81,"investigatorFullName":65,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Lecturer, PhD","100613029",false,"NCT07261267","Music Therapy's Effect on Cancer Patients Undergoing Radiotherapy","The Effect of Music Therapy on the Radiotherapy Experience of Cancer Patients Undergoing Radiotherapy: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Must be a cancer patient 18 years of age or older.\n* Must be newly starting curative external radiotherapy.\n* Must volunteer to participate in the study and sign the Informed Consent form.\n\nExclusion Criteria:\n\n* Having an advanced stage psychiatric disorder (e.g., schizophrenia).\n* Having hearing loss.\n* Having a prior history of an adverse reaction to music therapy.\n* Receiving radiotherapy for palliative (symptom relief) purposes.\n* Having received radiotherapy previously (for reasons such as brachytherapy, a different type of cancer, or recurrence).","ALL","18 Years",{"count":92,"type":93},72,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of this randomized controlled clinical study is to learn about the effects of music therapy on anxiety, stress, pain, and patient satisfaction in cancer patients who are newly starting radiotherapy (radiation treatment).\n\nThe main questions it aims to answer are:\n\nCan music therapy lower the levels of anxiety and stress in patients receiving radiotherapy? Can music therapy improve the pain felt during the radiotherapy experience and overall satisfaction? Researchers will compare patients receiving standard radiotherapy (control group) with patients receiving music therapy alongside their radiotherapy (experimental group).\n\nParticipants (72 total) will:\n\nBe 18 years and older and newly starting curative radiotherapy. Answer short surveys (STAI-SF, SDT, VAS) to measure their anxiety, stress, and pain levels before and after treatment.\n\nParticipants in the experimental group will receive a 15-20 minute music therapy session consisting of meditative and instrumental music during their first radiotherapy session.\n\nThis study aims to provide reliable data to guide clinical practice by showing whether music therapy offers a multifaceted approach to managing the psychological and physical challenges associated with cancer treatment.",[99,100],"Cancer","Radiotherapy",[56,100,102,103,104],"Anxiety","Pain","Stress","NOT_YET_RECRUITING","2025-11-21",{"date":108,"type":109},"2025-12-03","ACTUAL",{"date":111,"type":93},"2025-12-01",{"date":113,"type":93},"2026-01-31",{"name":5,"class":6},1]